NCT04420728

Brief Summary

This study will is a parallel two-group randomized controlled trial that will use the MiniMed 670G hybrid closed-loop system's continuous glucose monitor (GCM) insulin pump and computer algorithm to deliver insulin when in "auto mode". This study will be conducted in women with type 1 diabetes after delivery of their neonate to see if "auto-mode" improves blood sugar control, episodes of low blood sugar, burden of diabetes self-care, alters baby's weight and feeding patterns, and partner diabetes distress.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

July 15, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

May 23, 2023

Status Verified

May 1, 2023

Enrollment Period

2.6 years

First QC Date

March 24, 2020

Last Update Submit

May 19, 2023

Conditions

Diabetes Mellitus Type 1 Pre-ExistingPregnancy RelatedFeeding BehaviorInfant Development

Outcome Measures

Primary Outcomes (1)

  • Effect of Auto vs. Manual Mode of MiniMed 670G on Time in Target Range Assessed via CGM

    In postpartum women, with type 1 diabetes does use of the MiniMed 670G hybrid closed-loop system, enabled with auto mode compared with the MiniMed 670G in manual mode result in more time in target range (3.9 to 10 mmol/L) assessed by CGM?

    12 weeks postpartum

Secondary Outcomes (8)

  • Effect of Auto vs. Manual Mode of MiniMed 670G on Time Spent Below Target Range Assessed via CGM

    12 weeks postpartum

  • Effect of Auto vs. Manual Mode of MiniMed 670G on Time Spent Above Target Range Assessed via CGM

    12 weeks postpartum

  • Effect of Auto vs. Manual Mode of MiniMed 670G on Glycemic Variability Assessed via CGM

    12 weeks postpartum

  • Effect of Auto vs. Manual Mode of MiniMed 670G on Diabetes Self-Care Assessed via Diabetes Distress Scale 3

    12 weeks postpartum

  • Effect of Auto vs. Manual Mode of MiniMed 670G on Quality of Life Assessed via Diabetes Distress Scale 3 and the Hypoglycemia Fear Survey Questionnaire II

    12 weeks postpartum

  • +3 more secondary outcomes

Other Outcomes (6)

  • Effect of Auto vs. Manual Mode of MiniMed 670G on Infant Feeding Practices Assessed via Child Food and Liquid Intake Questionnaire

    12 weeks postpartum

  • Impact of Weaning on Total Daily Insulin Requirement on Women who Discontinue Lactation

    24 weeks postpartum

  • Effect of Auto vs. Manual Mode of MiniMed 670G on Sugar Concentrations in Breast Milk Assessed by Liquid Chromatography

    12 weeks postpartum

  • +3 more other outcomes

Study Arms (2)

Early auto-mode enabled

EXPERIMENTAL

Auto mode continuous glucose monitoring enabled 2-10 days post-partum

Combination Product: Early auto-mode

Delayed auto mode enabled

ACTIVE COMPARATOR

Auto mode continuous glucose monitoring enabled 12 weeks post-partum

Combination Product: Delayed auto mode

Interventions

Early auto-modeCOMBINATION_PRODUCT

Participant will be switched to or continue to use the MiniMed 670G insulin pump in manual mode during pregnancy. After the birth of their child, each participant will be randomized to either early auto-mode enabled MiniMed 670G or delayed auto-mode.

Early auto-mode enabled
Delayed auto modeCOMBINATION_PRODUCT

Participant will be switched to or continue to use the MiniMed 670G insulin pump in manual mode during pregnancy. After the birth of their child, each participant will be randomized to either early auto-mode enabled MiniMed 670G or delayed auto-mode.

Delayed auto mode enabled

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged 18 to 45, with at least a two year duration of type 1 diabetes, on intensive insulin therapy (at least 3 daily insulin injections or insulin pump) with a Hba1c during pregnancy \< 9.9 % at study entry who are confirmed by ultrasound, to have a viable singleton pregnancy between 12 and 32 weeks gestation and are not planning to conceive another pregnancy in the first 24 weeks postpartum.

You may not qualify if:

  • Non-type 1 diabetes
  • Any other physical or psychological disease which, in the opinion of the investigator, is likely to interfere with the normal conduct and interpretation of the study results
  • Current treatment with drugs known to interfere with glucose metabolism as judged by the investigator such as high dose systemic corticosteroids, non-selective beta-blockers and MAO inhibitors.
  • Known or suspected allergy against insulin.
  • Women with advanced nephropathy (eGFR\<45), severe autonomic neuropathy, uncontrolled gastroparesis or severe proliferative retinopathy, as judged by the investigator, that is likely to interfere with the normal conduct of the study and interpretation of study results.
  • Total daily insulin dose of less than 8 or greater than 250 units/day.
  • Severe visual or hearing impairment
  • Unable to speak and understand English (or French)
  • Planning to conceive another pregnancy within the first six months postpartum

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Calgary

Calgary, Alberta, T2T 5C7, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5T 3L9, Canada

Location

Related Publications (1)

  • Donovan LE, Bell RC, Feig DS, Lemieux P, Murphy HR, Sigal RJ, Ho J, Virtanen H, Crawford S, Yamamoto JM. Glycaemic patterns during breastfeeding with postpartum use of closed-loop insulin delivery in women with type 1 diabetes. Diabetologia. 2024 Oct;67(10):2154-2159. doi: 10.1007/s00125-024-06227-z. Epub 2024 Jul 19.

    PMID: 39028360DERIVED

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

March 24, 2020

First Posted

June 9, 2020

Study Start

July 15, 2020

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

May 23, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)